Technical service diagnostic tool for a sound processor

ABSTRACT

Diagnosis means, in the form of a software tool, for on-site diagnosis of a sound processor of an implanted prosthesis. The diagnosis means assesses hardware components and programming functions of the sound processor and accesses and assesses patient data stored in the sound processor. An activity log or report based on the assessment is available. Updated data and functions pertaining to a patient are retrieved and applied to the diagnosis means. The diagnosis means can replace the patient data and/or programming functions of the sound processor in the event of patient data corruption or programming function error in the sound processor. A method of on-site diagnosis of a sound processor and a process for diagnosis and repair of a sound processor of an implanted prosthesis are also disclosed.

FIELD OF THE INVENTION

The present invention relates to the diagnosis and technical servicingof a sound processor for a prosthesis, and in particular to a tool toassist in diagnosing, analysing, servicing and initialising a soundprocessor for a cochlear implant.

DESCRIPTION OF THE PRIOR ART

Hearing aids and cochlear implants have been proven to be useful inrestoring the sensation of hearing to hearing impaired individuals.

In cases of mild hearing loss, wherein the essential structures of thecochlea are intact and the hair cells are able to detect the mechanicalvibration of the cochlea fluid and transfer this into a neural impulsedetected by the brain as sound, hearing aids are commonly used. Suchhearing aids typically magnify the sound normally heard by theindividual so that the individual experiences this sound sensation at anequivalent level to that experienced by a normal hearing listener.

In cases where the hair cells of the cochlea have been damaged to theextent that they are no longer able to transfer the mechanical vibrationof the cochlea fluid into an electrical signal, traditional hearing aidsare of no use. In such situations where there is a severe or profoundhearing loss, cochlea implants have been developed to restore thefunction of hearing to affected individuals. One such implant isdescribed in U.S. Pat. No. 4,532,930, the contents of which areincorporated herein by reference. The cochlear implant bypasses the roleof the hair cells and directly delivers electrical stimulation to thenerves in the cochlea, representative of speech and environmentalsounds, with the neural impulses generated by such electrical signalsbeing sent to the brain and being interpreted as sound. The electricalstimulation is usually delivered to selected nerve sites within thecochlea by an array of electrodes, electrically connected to animplanted stimulator device.

Traditionally, the implanted stimulator device receives a coded soundsignal from an external sound processor device and from this codedsignal the implanted stimulator directs the appropriate electricalstimulation to be provided to the appropriate electrode to reproduce thecorresponding sound. The implanted stimulator is equipped withelectronic circuitry and switches to allow stimulation to be deliveredto a number of electrodes simultaneously or in very quick succession toprovide detailed sound perception.

The external sound processor provides the coded signal to the implantedstimulator via a transcutaneous link, such as an RF link, and the codedsignal is directly representative of the surrounding sound as detectedby an external microphone. The external microphone may be mounted on theexternal sound processor or may be remote from the external soundprocessor but connected via a suitable link.

With continuing technological advancements, it may be possible toprovide a system which is totally implantable within the head of theuser, such that an internal microphone is capable of detecting theexternal environmental sounds. In such a system the sound processorwould also be implanted within the head of the user and process thesound signal in much the same way as the previously described system.

In such a system, the basic function of the sound processor is to takean audio signal from a microphone and to process it according to aparticular speech coding strategy, to produce a signal that containsstimulation information for the implant. In earlier speech codingstrategies, the processor attempted to identify the important soundspresent in the signal (such as speech) and encode them as patterns ofelectrical stimulation. In more recent strategies, the full range ofspectral and temporal information in the audio signal has been providedto the user without any attempt by the processor to fit it into apreconceived mould.

In general, speech processors are quite patient specific and whilst thesystem hardware is relatively common for all users, the software used aswell as the benefits gained for different software packages variesconsiderably from patient to patient. This is due in the main to thefact that the degree of deafness and structures of the cochlea aredifferent from individual to individual and depend greatly on the causeof the deafness as well. Therefore the speech processors need to takeinto consideration such user variations and appreciate that stimulationof a specific amplitude on a specific electrode for one individual willcause a completely different sensation to the same stimulation ofanother individual. Hence, specific user parameters form an importantpart of most speech coding strategies.

It is important to then realise that in providing cochlear implants andin supporting the continual use of such implants, there will always be aneed to deal with each user on an individual basis to ensure that theyare receiving maximum benefit from the device.

This becomes particularly important following the implantation of acochlear implant, and in the follow up support and service thataccompanies such a procedure. Typically, following the surgicalimplantation of a device the user must have the device correctly fittedor programmed to ensure that the operation of the device is modified totake into consideration individual characteristics, such asactive/inactive electrodes and individual comfort and threshold levelsfor each channel of stimulation.

Over time and as the brain and body adjust to the implant it may benecessary to further modify the user parameters to maintain optimumperformance of the implant, and it is important that such services areprovided over the lifetime of the individual. As well as adjusting andcreating patient specific individual user stimulation maps, it is alsoimportant that support is provided should any problems occur with thedevice hardware. Such a support service is crucial and needs to beorganised and detailed enough to ensure that any problems anddifficulties that affect the performance of the device are dealt withswiftly and efficiently to ensure that the user does not experienceextended periods of inoperation.

Experience has shown that the cause of malfunctions is often hard topinpoint, and in order to correctly diagnose problems a good knowledgeof all the functionality of the device is required, together with aconsiderable amount of experience with such devices. The reason for thisis that any perceived problem could be a direct consequence of thevariety of elements that influence the device performance, for example,the device hardware, the embedded software, the installed software, thecoding strategies used and also the recipient specific parameters (suchas stimulation maps and the like).

At present, in the unfortunate event of a user experiencing a difficultyor malfunction that causes them to lose system functionality, the userneeds to contact a local clinic/agent who has been assigned to deal withsuch issues. This clinic/agent is usually familiar with the individual'sneeds and requirements and has full records of the patient specificparameters of the associated speech processing strategies. Should anindividual experience a problem it is the role of the clinic/agent toattend with this problem and rectify it as soon as possible so that theuser experiences minimal inconvenience. Quite often this problem mayreside in faulty connection of leads or battery terminals, and can bemerely rectified by replacing the faulty leads or batteries, withoutrequiring any further action.

Should a fault occur with an individual's external sound processor,rendering the device ineffective, the problem becomes more serious. Insuch instances the sound processor must be fully checked by themanufacturer or an authorised agent of the manufacturer, and as such itis likely that the speech processor must be taken from the patient andshipped to such a repair area. In such instances the clinic/agent issuesthe user with a temporary replacement device and loads the patientspeech coding algorithms and the patient parameter settings into thereplacement device so that the implant can function properly whilst theuser's own device is being investigated and repaired.

Whilst all effort is made to protect against device malfunctions, withelectronic devices such as an external speech processor, it is difficultto ensure that malfunctions will not occur due to the nature of thedevice and the amount of use such a device receives. Also as the soundprocessor is responsible for coding the stimulation information to bedelivered by the implanted stimulator, it is important that any systemmalfunction is fully investigated to ensure that the user does notreceive improper stimulation which may have adverse effects. This is whyall sound processor problems are sent to the supplier or manufacturer toinvestigate and report to ensure the integrity of all devices returned.

Nevertheless, it has been found that a large number of speech processors(20-25%) that have been reported as being malfunctions/faulty andreturned to the supplier or manufacturer for investigation have beenfound to have no mechanical or electrical problems and function normallywhen tested. In such instances the problems have resided in corruptedpatient data or programming data stored on the sound processor. This mayhave occurred as a result of the sound processor being exposed toabnormal environmental conditions, such as extreme electrical, magnetic,thermal, mechanical or chemical forces, or even as a result of aninadvertent power failure or batteries being replaced in an incorrectmanner.

Any discussion of documents, acts, materials, devices, articles or thelike which has been included in the present specification is solely forthe purpose of providing a context for the present invention. It is notto be taken as an admission that any or all of these matters form partof the prior art base or were common general knowledge in the fieldrelevant to the present invention as it existed before the priority dateof this application.

Throughout this specification the word “comprise”, or variations such as“comprises” or “comprising”, will be understood to imply the inclusionof a stated element, integer or step, or group of elements, integers orsteps, but not the exclusion of any other element, integer or step, orgroup of elements, integers or steps.

SUMMARY OF THE INVENTION

According to a first aspect, the present invention provides a method foron site diagnosis of a processor of an implantable prosthesis, themethod comprising the steps of:

testing functionality of a hardware component of the processor;

assessing data stored by the processor; and

assessing software functions of the processor.

By undertaking such assessment steps on-site, the present inventionenables a recipient, clinician or the like to determine whether or not aperceived fault is in fact a fault requiring dispatch of the processorto a repair facility. As noted previously, perhaps 20%-25% of perceivedfaults do not require dispatch of the processor to a repair facility,and the present invention provides a manner in which an assessment ofthe fault perceived by the recipient can be carried out on site and ifpossible, rectified on-site, prior to dispatch of the processor to therepair facility. Even in cases in which a fault exists requiringdispatch of the processor to a repair facility, the present inventionenables closer identification of the fault to be obtained on site, whichcan be provided to the repair facility along with the sound processor toease the task of the repair facility.

It is to be understood that on-site diagnosis in accordance with thepresent invention involves diagnosis of the sound processor remote froma repair facility provided by, for example, a manufacturer. Such on-sitediagnosis may comprise diagnosis by a recipient of the implant at theirown home, or may comprise diagnosis by a clinician at a clinic.

The present invention preferably further comprises one or more of thesteps of:

restoring functionality of the sound processor;

reporting on performance of the sound processor; and

checking the effectiveness of restored functions of the sound processor.

In particular, the step of restoring functionality of the soundprocessor may comprise one or more of the following:

restoring software functions of the processor; and

restoring data stored by the sound processor.

Similarly, the step of reporting on performance of the sound processormay comprise assembling an activity log with performed functions, errorsand warnings, and reporting the activity log to a predeterminedrecipient. The activity log may assemble the functions errors andwarnings at several levels of detail, and may report at a level ofdetail which corresponds to the predetermined recipient of the activitylog. That is, depending on the identity of the predetermined recipientof the activity log, such as the implant recipient, the clinician, orthe implant manufacturer, the level of detail of each of the elements ofthe activity log may be varied accordingly.

Preferably, the method of the present invention further comprises thestep of prior to assessing and testing the sound processor, checking forupdated assessment methodology. For instance, such a step may comprisechecking for new data to be installed to the sound processor, orchecking for new software functions to be installed to the soundprocessor. Such a step provides for“self-updating” of the method of thepresent invention, for example by requesting a repair facility orimplant manufacturer whether such new data or software functions exist.Such a step may be performed over the internet, and may be performed bya diagnosis tool without user intervention so as to provide automatedself updating.

In accordance with the present invention, correct diagnosis of theproblem on-site could significantly reduce the repair time and avoid theneed to send the processor a long distance to a repair facility for afull analysis, when the fault could be repaired on the spot by reloadingthe associated data onto the processor, followed by a full functionalanalysis. Further, by performing a detailed diagnosis and possibledevice repair at the user's own home or at the clinician's initial pointof contact with the user, the total disruption experienced by the usercould be significantly reduced.

Even further, by allowing a detailed diagnosis of the device to occurimmediately when the device is thought to malfunction, either directlyby the recipient themself, or when the device has been received by theclinic/agent, an immediate indication of the type of problem experiencedand the likely time such a problem would take to repair can be providedto the recipient. Additionally, this repair time would most likely befurther reduced as the supplier repair team would be presented with arelatively detailed diagnosis report which would point to the source ofthe problem, without having to perform a full diagnostic check toisolate the problem.

In addition to the above mentioned time savings, there are further timesavings achievable and increased recipient satisfaction by allowing therecipient to perform self diagnosis and rectification of minor problemssuch as restoration of coding strategies and recipient parameters,themselves, without the need to visit a specialist or dedicated clinic.

Preferably, the method of the present invention further enables on-siterectification of at least some faults to be performed. Accordingly themethod of the present invention preferably further comprises, in theevent of patient data corruption in the speech processor, retrieving abackup copy of the patient data and replacing the patient data of theprocessor. The step of retrieving the backup data may compriseretrieving the backup data from a floppy disk, CD ROM or the like keptby the patient, or alternatively may comprise retrieving the backuppatient data from a central data storage maintained, for example, by aproducer of the prosthesis, or by a repair facility to which theprocessor would otherwise be sent. Alternatively, the step of retrievingmay comprise retrieving the backup patient data from a local storagemeans such as a clinician's personal computer or the recipient'spersonal computer. The step of retrieving may comprise retrieving thebackup copy of the patient data locally, or retrieving the backup copyover a network, such as the internet

Similarly, the method of the present invention preferably furthercomprises, in the event of programming function error in the processor,reinstalling the programming functions to the processor. Again, theprogramming functions may be retrieved from a floppy disk or CD ROM orthe like kept by the patient, or from a central data repositorymaintained, for instance, by a maker of the prosthesis. Alternativelythe programming functions may be retrieved from an on site storagedevice, such as a clinician's personal computer. In the event ofprogramming function error in the processor, the identified error ispreferably referred back to an implant manufacturer or a repairfacility, and is preferably referred back to a rehabilitation centreassociated with the recipient of the implant. In the event of adetection that the programming functions of the processor deviate fromthe standard and suspicious programming elements are identified, thepresent invention preferably signals warnings to the manufacturer and/orrepair facility and to the rehabilitation centre, referring therecipient to see their audiologist or clinician, and recommending thatthe device not be sent to a repair facility for unneeded repair.

According to a second aspect the present invention provides a diagnosismeans for on site diagnosis of a processor of an implanted prosthesis,the diagnosis means comprising:

means to assess hardware components of the processor;

means to access and assess stored patient data of the processor; and

means to assess programming functions of the speech processor.

It is envisaged that the diagnosis means will comprise an appropriatelyprogrammed and configured computer, able to connect to the processor andcarry out the steps of assessment of the processor. Alternatively thediagnosis means may comprise a hand held device having an applicationspecific integrated circuit (ASIC), operable to perform the desireddiagnosis steps.

The diagnosis means may assess the processor in order to verify whethera fault perceived by an implant recipient actually exists prior todispatch of the processor to a clinic or repair facility, and mayproduce a detailed activity log based on said assessment. The report maybe provided to a processor repair facility along with the processor ifthere is a need to send the processor for repair. Such an activity logmay additionally or alternatively be provided to the implant recipient,or to a clinician or rehabilitation centre associated with the implantrecipient.

In preferred embodiments of the invention the diagnosis means is furtheroperable to undertake on site correction or repair of certain faultswhich may arise within the processor. Accordingly, the diagnosis meanspreferably further comprises means for replacing the patient data of theprocessor in the event of patient data corruption in the processor. Insuch embodiments, the diagnosis means is preferably operable to retrievea back up copy of the patient data from a floppy disk or CD ROM or thelike kept by the patient, or from a central data repository maintained,for instance, by a maker of the implanted prosthesis or by a repairfacility. Alternatively, the diagnosis means may itself store a copy ofthe patient data.

The diagnosis means may further comprise means for retrieving updatesand applying such updates to the diagnosis means. For example, the meansfor retrieving updates may communicate with a remote network sitemaintained, for example, by a repair facility or an implantmanufacturer, in order to determine whether the diagnosis means requiresupdating. The retrieved updates may comprise updated patient data,updated implant software functions, or updated functionality of thediagnosis means itself

Similarly, the diagnosis means preferably further comprises means forreinstalling the programming functions to the processor in the event ofprogramming function error in the processor. Again, the programmingfunctions may be retrieved by the diagnosis means from a floppy disk orCD ROM or the like kept by the patient, or from a central datarepository maintained, for instance, by a maker of the implantedprosthesis or by a repair facility. Alternatively, the diagnosis meansmay itself store a copy of the programming functions for installation tothe processor in the event of programming function error within theprocessor.

In accordance with the method and diagnosis means of the presentinvention, the implanted prosthesis may comprise a cochlea implant, andthe processor may comprise a sound processor for converting receivedsounds into an electrical signal to be applied by an implantedstimulator portion of the cochlea implant. In such embodiments, thepatient data of the sound processor assessed by the diagnosis means willtypically comprise data such as threshold level, comfort level, and thelike. The programming functions of the sound processor assessed by thediagnosis means will typically comprise functions for convertingreceived audio sound detected by a microphone associated with the soundprocessor into electrical stimulation signals to be passed to animplanted stimulation portion of the implant, using such patient data asthreshold level, comfort level and the like.

According to a third aspect, the present invention provides a processfor diagnosis and repair of a sound processor of an implantedprosthesis, the process comprising:

a recipient of the implanted prosthesis performing an on-site diagnosisof the sound processor using a recipient diagnosis and repair tool;

the recipient repairing identified errors within the capability of therecipient diagnosis and repair tool;

in the event of identifying an error which is not within the repaircapability of the recipient's on-site diagnosis and repair tool, aclinician performing an on-site diagnosis of the sound processor using aclinician diagnosis and repair tool;

the clinician repairing identified errors within the capability of theclinician diagnosis and repair tool; and

in the event of identifying an error which is not within the repaircapability of the clinician diagnosis and repair tool, providing thesound processor to a repair facility.

The present invention further provides for a computer readable memoryencoded with data representing a computer program for controlling acomputer to execute a procedure according to any one of the method stepsherein disclosed.

The present invention also provides for a computer program elementcomprising computer program code means for controlling a computer toexecute a procedure according to any of the method steps hereindescribed.

BRIEF DESCRIPTION OF THE DRAWINGS

Examples of the invention will now be described with reference to theaccompanying drawings in which:

FIG. 1 is a pictorial representation of a cochlear implant system; and

FIG. 2 is a flowchart illustrating a sound processor diagnosis method inaccordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before describing the features of the present invention, it isappropriate to briefly describe the construction of a cochlear implantsystem with reference to FIG. 1.

Cochlear implants typically consist of two main components, an externalcomponent including a sound processor 29, and an internal componentincluding an implanted receiver and stimulator unit 22. The externalcomponent includes an on-board microphone 27. The sound processor 29 is,in this illustration, constructed and arranged so that it can fit behindthe outer ear 11. Alternative versions may be worn on the body or it maybe possible to provide a fully implantable system which incorporates thespeech processor and/or microphone into the implanted stimulator unit.Attached to the sound processor 29 is a transmitter coil 24 whichtransmits electrical signals to the implanted unit 22 via an RF link.

The implanted component includes a receiver coil 23 for receiving powerand data from the transmitter coil 24. A cable 21 extends from theimplanted receiver and stimulator unit 22 to the cochlea 12 andterminates in an electrode array 20. The signals thus received areapplied by the array 20 to the basilar membrane 8 thereby stimulatingthe auditory nerve 9. The operation of such a device is described, forexample, in U.S. Pat. No. 4,532,930.

The sound processor 29 of the cochlear implant can perform an audiospectral analysis of the acoustic signals and outputs channel amplitudelevels. The sound processor 29 can also sort the outputs in order ofmagnitude, or flag the spectral maxima as used in the SPEAK strategydeveloped by Cochlear Ltd.

Turning now to FIG. 2, a sound processor diagnosis method in accordancewith the present invention is illustrated. In current methods, when apatient experiences a problem with a sound processor they contact theirnearest clinic/agent to investigate and correct the problem. Once theclinic has performed an initial superficial check of the processor andassessed that the problem cannot be easily corrected through replacementof the external connector leads or through a faulty connection betweenleads, the problem is essentially beyond the capabilities of theclinician and needs to be sent back to the original supplier for a morethorough examination.

A replacement device is usually supplied to the individual whilst thedevice is returned to the supplier for repair and investigation. Thereplacement device is loaded with the individual's specific individualrequirements (maps) and the individual can leave the clinic with a fullyfunctional device whilst they await repair and return of their owndevice. Except in exceptional circumstances, the individual's own deviceis always repaired and returned to the individual.

In the first instance, the present embodiment of the invention allowsthe recipient to check, load and assess their device should aproblem/malfunction be evident, or merely as a routine check to ensurethat all is in order with the device or to perform regular updates ofthe device. In the event that a problem exists with the device that therecipient can not rectify, the recipient is then directed to approach aclinician or rehabilitation centre where the matter can be resolved orinvestigated further, and if required, a replacement device obtained.

The present invention therefore provides a software tool that enables acheck, diagnosis, reporting and repair service of perceived faulty soundprocessors. The software tool assesses the sound processor for fatalerrors associated with faulty hardware or with a fatally corruptedvolatile memory, software and embedded hardware, and also assesses thesound processor for repairable errors such as one or more alteredsettings or corrupted stored data, all of which can be repaired by thetool.

FIG. 2 shows a flow chart illustrating operation of the software tool ofthe present invention. Initially, the sound processor of concern ischecked for obvious problems that would affect its functionality, suchas faulty batteries, incorrect lead connections and the like. In theevent of an obvious problem being found, it is corrected so that a moredetailed check of the system can be performed.

The sound processor is then connected to the software tool of thepresent invention which can be run through a common PC or similarinterface.

First, the tool opens a log entry at 30, where all performed functionsand outcomes are stored for the particular session. At 40 the tool canperform a self check whereby it searches for any available updates forthe device components or for the sound processor function or datalibraries. This self check ensures that the device is up to date andcontains the most recent system changes applicable for the particularrecipient. The self check can interrogate data stored on a centraldatabase via the internet or other type of network, wherein the centraldatabase contains all system component updates and recipient dataupdates.

Once the self check 40 has been performed, the tool performs acommunication integrity test 50 to assess that the tool is able tocommunicate with the core of the sound processor, that is, the CPU ormicro-controller. Should this integrity test 50 produce an errorindicating a problem with the communication channels to the CPU, fartherinvestigation of the device is not possible and the tool at 51 issues areport of a fatal error and advises the recipient that the device mustbe sent to the manufacturer/supplier for repair. If the integrity test50 indicates the communication channels are operable, the tool continuesthe procedure.

Subsequently, at 60, the tool performs an integrity test of the speechprocessor's micro-controller, by comparing the CPU functionality and itsembedded code with the original design code which is known and accessedby the tool from a function library. During this assessment testcommunication of the main internal components of the sound processor isalso addressed. This step essentially resides in the tool accessingspecific top level programs from a stored file within a PC or via acentral storage database and comparing such programs with those storedon the device. Should there be any inconsistencies found, the toolceases the test and, at 61, issues a report indicating that a fatalerror exists within the micro-processor and suggests that the device bereturned to the supplier for further investigation at 62. Should therebe no inconsistencies found, the tool continues with the test.

Following the assessment that the basic hardware and embedded softwareof the sound processor is in order, the tool then begins an assessmentof the patient specific functions and data that are stored on thedevice. Whilst sound processors are typically constructed in such a waythat they can be mass produced, all sound processors in use arespecifically designed to take into consideration patient specificfunctions, data, and sound strategies, all of which are stored withinthe sound processor and form an integral part of the sound processor.Therefore should an individual use another person's sound processor withtheir own implant, they would experience a quite different hearingsensation, one not optimised with their own specific characteristics.

Accordingly, the next step 70 is to download the specific patient'sindividual strategies, functions, data and settings from an externalsource such as a floppy disk which the patient carries with them or viaa global database that stores such information.

Once this data has been downloaded by the tool, the tool then checks at80 whether the serial number embedded within this data matches with theserial number of the sound processor. Should there be an inconsistencywith the serial number, the tool makes note of the problem and at 81issues a warning to its user indicating that the recipient is using asound processor that is not assigned to them.

Should the serial numbers agree, the tool makes a memory map sorting allthe strategies, functions, data and settings retrieved from the externalsource and reference libraries provided with the tool, in the order asthey appear in the sound processor's memory (ROM and RAND. This map isfurther referred to as the virtual memory map.

Next, an initial assessment of the patient specific data is performed at90 which checks the stored values with design limits and notes anyunusual values. The patient specific data or fitting data containsvalues which correspond to individual stimulation thresholds and comfortlevels and should this information be incorrect malfunctions can occurdue to incorrect fitting data. Even if the tool identifies any data thatappears to be beyond the design limits the tool does not attempt tocorrect such data, but merely makes a note of the deviations at 91, andincludes such matters in the final report.

At 100, the diagnosis tool compares the virtual memory map with thestrategies, functions, data and settings as stored on the device. As thevirtual memory map is indicative of what should be stored on the soundprocessor, derived from the most recent fitting session, and libraries,should there be an inconsistency between the two, the tool at 110attempts to automatically correct this data in the sound processor. Inthe event that there is an inconsistency, the tool deletes thestrategies, functions, data and settings stored on the sound processorand attempts a re-write of the data. At 111, a note is made of suchcorrections for inclusion in the final report. Following this re-writeanother comparison is performed at 120 to check whether the data doescorrespond. If there still exists an inconsistency with the data thenthe tool terminates the test and issues a fatal error warning at 121stating that the memory in the sound processor is corrupt at aparticular address and requires attention from the supplier at 122.

Should the correction be successful and both the virtual memory map andthe data stored on the sound processor correspond, the tool will deletethe data on the sound processor another two times but in different waysand each time re-write and compare with the virtual memory map onceagain. By doing so, sufficient confidence is built up to assess thisinitial data corruption as non repeatable and consequently the tool willdetermine that the sound processor may be released for further use. Thetest is then complete and a log is made available at 130 which providesa history of all tested functions and the changes made, together withany recommendations.

Depending on the user of the tool, the tool issues a report at anappropriate level for that user, on screen or by way of any other outputdevice connected with the tool.

Depending upon this report the user either sends their sound processorto the clinic, agent, or first point of contact together with a copy ofthe report indicating the problem(s) found, or stores a copy of thereport on the individual's file for future reference.

In any event the tool of the present embodiment of the present inventionprovides a thorough diagnostic and repair device which greatly improvesthe service that a clinician can provide to a cochlear implant patient,and reduces the time and effort that is required by the repair team ofthe device suppliers as they no longer are confronted with problems thatrequire a minor correction, and are given a more detailed diagnosis of aproblem which they can more clearly target.

As has been described, the present invention relates to an on-site andeasily accessible tool, the strategy adopted in using the tool indiagnosing problems in a sound processor for a cochlear implant or thelike, and to analysing, initialising, and loading recipient specificdata into such a sound processor. Also the strategy to feedback themanufacturer of the sound processing device, and the means used by thetool fall under this disclosure.

It will be appreciated by persons skilled in the art that numerousvariations and/or modifications may be made to the invention as shown inthe specific embodiments without departing from the spirit or scope ofthe invention as broadly described. The present embodiments are,therefore, to be considered in all respects as illustrative and notrestrictive.

1. A method of on-site diagnosis of a sound processor of an implantableprosthesis, the method comprising the steps of: testing functionality ofa hardware component of the sound processor; assessing data stored bythe sound processor; and assessing software functions of the soundprocessor.
 2. A method according to claim 1 further comprising the stepof performing the on-site diagnosis remotely from a repair facility. 3.A method according to claim 2 wherein the diagnosis is conducted by apredetermined user, such as the recipient of the prosthesis or aclinician.
 4. A method according claim 1 further comprising the step ofrestoring functionality of the sound processor.
 5. A method according toclaim 4 further wherein the step of restoring functionality of the soundprocessor comprises restoring software functions of the sound processor.6. A method according to claim 4 further wherein the step of restoringfunctionality of the sound processor further comprises restoring datastored by the sound processor.
 7. A method according to claim 1 furthercomprising the step of reporting on performance of the sound processor.8. A method according to claim 7 wherein the step of reporting onperformance of the sound processor comprises the steps of assembling anactivity log with performed functions, errors and warnings and reportingthe activity log to a predetermined user.
 9. A method according to claim8 wherein the activity log assembles the performed functions, errors andwarnings at several levels of detail, reporting the activity log at alevel of detail corresponding to the identity of the predeterminedrecipient of the activity log.
 10. A method according to claim 1 furthercomprising the step of, prior to assessing and testing the soundprocessor, checking updated assessment technology.
 11. A methodaccording to claim 10 wherein the step of checking updated assessmenttechnology comprises checking for new data or new software functions tobe installed to the sound processor.
 12. A method according to claim 1further comprising the steps of retrieving a backup copy of patient dataand replacing the patient data of the sound processor in the event ofpatient data corruption in the sound processor.
 13. A method accordingto claim 12 wherein the step of retrieving a backup copy of patient datacomprises retrieving the backup data from a floppy disk, CD-ROM or thelike kept by the predetermined user.
 14. A method according to claim 12wherein the step of retrieving a backup copy of patient data comprisesretrieving the backup data from a central data storage means.
 15. Amethod according to claim 12 wherein the step of retrieving a backupcopy of patient data comprises retrieving the backup data from a localdata storage means.
 16. A method according to claim 12 wherein the stepof retrieving a backup copy of patient data comprises retrieving thebackup data over a communications network.
 17. A method according toclaim 1 further comprising the step of reinstalling programmingfunctions to the sound processor in the event of programming functionerror in the sound processor.
 18. A method according to claim 17 whereinthe programming functions are retrieved from a data storage medium, suchas a floppy disk or CD-ROM, or from a central or local data storagemeans.
 19. A method according to claim 17 further comprising the stepof, in the event of programming function error in the sound processor,referring the identified error to an implant manufacturer or repairfacility and to a rehabilitation centre associated with the recipient ofthe implant.
 20. A method according to claim 19 wherein in the event ofdetection that the programming functions of the sound processor deviatefrom the programming functions retrieved from any one of the datastorage medium, central data storage means or local storage means, themethod further comprises the steps of signalling warnings to themanufacturer or repair facility and to the rehabilitation centre thatthe implant recipient is to consult an audiologist or clinician, andrecommending that the sound processor not be sent to the repair facilityfor unneeded repair.
 21. Diagnosis means for on-site diagnosis of asound processor of an implanted prosthesis, the diagnosis meanscomprising: means to assess hardware components of the sound processor;means to access and assess stored patient data of the sound processor;and means to assess programming functions of the sound processor. 22.Diagnosis means according to claim 21 comprising a programmed andconfigured computer processor means operable to connect to the soundprocessor and carry out the assessment of the sound processor. 23.Diagnosis means according to claim 21 comprising a hand-held computerprocessing means operable to connect to the sound processor and carryout the assessment of the sound processor.
 24. Diagnosis means accordingto claim 21 wherein the sound processor is assessed in order to verifywhether a fault perceived by an implant recipient actually exists priorto dispatch of the sound processor to a clinic or repair facility. 25.Diagnosis means according to claim 24 producing an activity log based onthe assessment of the sound processor.
 26. Diagnosis means according toclaim 25 wherein the activity log is forwarded to the repair facilitytogether with the sound processor if the sound processor needsrepairing.
 27. Diagnosis means according to claim 26 wherein theactivity log is forwarded to any one or more of the implant recipient,clinician or rehabilitation centre associated with the implantrecipient.
 28. Diagnosis means according to claim 27 operable toretrieve a backup copy of the patient data from a data storage mediumsuch as a floppy disk or CD-ROM or the like kept by the implantrecipient or from a central or local data storage means.
 29. Diagnosismeans according to claim 28 having data storage means for storing abackup copy of the patient data.
 30. Diagnosis means according to claim28 wherein programming functions stored on the data storage medium areretrieved by the diagnosis means and compared with the programmingfunctions stored in the sound processor.
 31. Diagnosis means accordingto claim 30 wherein any inconsistency between the compared programmingfunctions is reported indicating that an error exists within the soundprocessor.
 32. Diagnosis means according to claim 28 wherein the patientdata is downloaded from any one of the data storage medium, central datastorage means or local data storage means to the diagnosis means. 33.Diagnosis means according to claim 29 wherein a comparison is madebetween the downloaded patient data and the patient data stored in thesound processor.
 34. Diagnosis means according to claim 33 wherein thecomparison includes comparing the serial number embedded within thedownloaded patient data and the serial number stored in the soundprocessor.
 35. Diagnosis means according to claim 34 wherein upon anymismatch between the serial number in the downloaded patient data andthe serial number stored in the sound processor, a warning is issued tothe recipient of the implant indicating use of a sound processor notassigned to them.
 36. Diagnosis means according to claim 34 whereupon amatch is found between serial numbers, the diagnosis means makes amemory map sorting all strategies, functions, data and settings formingthe patient data and/or programming functions retrieved from the datastorage medium in the order in which they appear in the sound processor.37. Diagnosis means according to claim 36 wherein the diagnosis meanscompares the memory map with the strategies, functions, data andsettings forming the patient data and/or programming functions stored inthe sound processor.
 38. Diagnosis means according to claim 37 furthercomprising means for replacing the patient data or programming functionsof the sound processor in the event of patient data corruption in thesound processor.
 39. Diagnosis means according to claim 38, whereuponany inconsistency between the memory map and the patient data orprogramming functions stored in the sound processor the diagnosis meanscorrects or rewrites the patient data or programming data in the soundprocessor.
 40. Diagnosis means according to claim 21 further comprisingmeans for retrieving updates and applying the updates to the diagnosismeans.
 41. Diagnosis means according to claim 40 wherein the means forretrieving updates communicates over a communications network with aremote site in order to determine whether the diagnosis means requiresupdating.
 42. Diagnosis means according to claim 41 wherein theretrieved updates comprises any one or more of updated patient data,updated implant software functions or updated functionality of thediagnosis means.
 43. Diagnosis means according to claim 21 furthercomprising means for reinstalling the programming functions to the soundprocessor in the event of programming function error in the soundprocessor.
 44. Diagnosis means according to claim 43 wherein theprogramming functions are retrieved from a data storage medium such as afloppy disk or CD-ROM or the like kept by the implant recipient or froma central or local data storage means.
 45. Diagnosis means according toclaim 43 having data storage means for storing a copy of the programmingfunctions for installation to the sound processor in the event ofprogramming function error within the sound processor.
 46. Diagnosismeans according to claim 21 wherein the implanted prosthesis comprises acochlea implant.
 47. Diagnosis means according to claim 46 wherein thesound processor converts received sounds into an electrical signal to beapplied by an implanted stimulator portion of the cochlea implant. 48.Diagnosis means according to claim 47 wherein the patient data comprisesany one or more of threshold level, comfort level or the like. 49.Diagnosis means according to claim 46 wherein the programming functionscomprise functions for converting received audio sound detected by amicrophone associated with the sound processor into electricalstimulation signals to be passed to the implanted stimulator portion ofthe cochlea implant using such patient data as threshold level orcomfort level.
 50. A process for diagnosis and repair of a soundprocessor of an implanted prosthesis, the process comprising the stepsof: a recipient of the implanted prosthesis performing an on-sitediagnosis of the sound processor using a recipient diagnosis and repairtool; and the recipient repairing identified errors within thecapability of the recipient diagnosis and repair tool.
 51. A processaccording to claim 50 wherein in the event of identifying an error whichis not within the repair capability of the recipient diagnosis andrepair tool, the process further comprises the step of a clinicianperforming an on-site diagnosis of the sound processor using a cliniciandiagnosis and repair tool.
 52. A process according to claim 51 furthercomprising the step of the clinician repairing identified errors withinthe capability of the clinician diagnosis and repair tool.
 53. A processaccording to claim 52 further comprising the step of providing the soundprocessor to a repair facility in the event of identifying an errorwhich is not within the repair capability of the clinician diagnosis andrepair tool.
 54. A computer program element comprising computer programcode means for controlling a computer to execute a procedure accordingto the method of claim
 1. 55. A computer readable memory encoded withdata representing a computer program for controlling a computer toexecute a procedure according to the method of claim 1.